Tobacco Smoking
Conditions
Keywords
E-cigarettes, Schizophrenia
Brief summary
The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.
Interventions
DRUGNicotine Patch
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
DRUGE-cigarette
The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be diagnosed with schizophrenia * Be in stable medical condition (DSM-V) * report smoking ≥10 tobacco cigarettes/day * present a breath CO ≥10 ppm * report wanting to reduce their cigarette smoking * be fluent in English * have a stable living situation
Exclusion criteria
* be currently pregnant or breastfeeding * report wanting to quit smoking in the immediate future * test positive for illicit drugs except THC * have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Smoking as Assessed by Breath Carbon Monoxide Levels | Baseline, Week 5 | — |
| Change in Smoking as Assessed by Urinary Cotinine Levels | Baseline, Week 5 | — |
| Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Baseline | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility as Assessed by Percent of Participants Who Completed the Study | week 5 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Replacement Therapy - Nicotine Patch Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. | 4 |
| Nicotine Replacement Therapy + E-cigarette Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Nicotine Replacement Therapy - Nicotine Patch | Total | Nicotine Replacement Therapy + E-cigarette |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 4.377 | 48.3 years STANDARD_DEVIATION 2.7 | 44.6 years STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 4 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Change in Smoking as Assessed by Breath Carbon Monoxide Levels
Time frame: Baseline, Week 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Change in Smoking as Assessed by Breath Carbon Monoxide Levels | -18 parts per million (ppm) | Standard Deviation 24 |
| Nicotine Replacement Therapy + E-cigarette | Change in Smoking as Assessed by Breath Carbon Monoxide Levels | -4.3 parts per million (ppm) | Standard Deviation 3.1 |
Primary
Change in Smoking as Assessed by Urinary Cotinine Levels
Time frame: Baseline, Week 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Change in Smoking as Assessed by Urinary Cotinine Levels | 0 ng/mL | Standard Deviation 0 |
| Nicotine Replacement Therapy + E-cigarette | Change in Smoking as Assessed by Urinary Cotinine Levels | 0 ng/mL | Standard Deviation 0 |
Primary
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | 13 number of cigarettes per day | Standard Deviation 6 |
| Nicotine Replacement Therapy + E-cigarette | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | 23 number of cigarettes per day | Standard Deviation 16 |
Primary
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Time frame: week 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | 9 number of cigarettes per day | Standard Deviation 7 |
| Nicotine Replacement Therapy + E-cigarette | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | 12 number of cigarettes per day | Standard Deviation 7 |
Secondary
Feasibility as Assessed by Percent of Participants Who Completed the Study
Time frame: week 5
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Feasibility as Assessed by Percent of Participants Who Completed the Study | 100 percent of participants |
| Nicotine Replacement Therapy + E-cigarette | Feasibility as Assessed by Percent of Participants Who Completed the Study | 100 percent of participants |